Medications, both drugs and non-drugs, may be introduced into a patient with the use of an infusion device, or with a variety of other types of medical devices. However, a patient's response to an introduced medication is not always immediate. To encourage a faster patient response, clinicians may introduce drugs into a patient at a rate or dosage that is relatively high. One form of a relatively large rate or dosage of medication is known as a bolus dose. The purpose of the bolus dose is to hasten or magnify a patient response.
Additionally, certain types of drug deliveries into a patient are made to maintain the presence of a drug in a patient over a period of time. These deliveries are known as maintenance deliveries, or maintenance doses. Prior to a maintenance dose, it is sometimes necessary to quickly bring the quantity of the drug in the patient to a level at which it can be maintained. To establish this maintenance level, clinicians may deliver drugs into a patient at a relatively high rate or dosage. This initial relatively large rate or dosage of medication is known as a loading dose. The purpose of the loading dose is to establish a level of medication in a patient, after which a maintenance dose can be used to maintain that level. A bolus dose or loading dose may be delivered with fluid of a drug, non-drug, or test substance, and may be given by intravenous, epidural, subcutaneous, or arterial routes.
Modern infusion devices provide for the manual entry of data into the infusion device, enabling the device to control the infusion of medication into the patient. The data provided to such devices describes the infusion therapy, and includes parameters such as drug volume, infusion rate, and the total time for which the infusion is to be made. Some of these devices provide for the entry of data reflecting multiple regimens, thus enabling the device to automatically control multiple infusions concurrently or sequentially.
A limited number of infusion devices are equipped with a memory which may store parameter data for standard continuous infusion protocols. Such devices enable a clinician to recall parameter data from a standard continuous infusion from the memory of the device. This feature provides two distinct advantages to the clinician. First, parameter data may be recalled quickly from the memory, without the need for re-entry of the parameter data. Thus, these memory-equipped infusion devices have the advantage of typically being faster to program than non-memory-equipped infusion devices. Second, since parameter data may be stored and retrieved, the need for re-entry of parameter data is less necessary, and thus the human error associated with data entry is minimized. Memory-equipped infusion devices enable the recall of safe infusion regimens, thus dispelling the need for human entry of potentially erroneous regimen data. Such devices are limited to the storage of standard infusion therapies.
These devices, however, do not provide the ability for the storage or recall of therapy data which provide for a bolus dose or loading dose infusion. Furthermore, since these devices do not store bolus dose or loading dose therapy data in the memory of the device, they do not provide for error-checking of clinician-entered bolus dose or loading dose therapies.
Accordingly, a need has arisen for a controller for an infusion device which provides for the storage of bolus dose and loading dose infusion therapy data in the memory of the infusion device. Such a device would provide for the recall of safe bolus dose and loading dose infusion therapy data, and therefore would provide for both faster and safer bolus dose or loading dose infusion control. Furthermore, the need has arisen for a controller for an infusion device which provides for error-checking of clinician-entered bolus dose or loading dose infusion therapy data. Such a device would provide for safer bolus dose or loading dose infusions by comparing clinician-entered data to recommended parameter limits stored in the device's memory.
Additionally, it is common to provide a medication to a patient in response to certain patient and disease conditions. Under these circumstances, a clinician is required to determine an appropriate infusion therapy based upon the condition of the patient. Sometimes, the amount of time required by the clinician to determine an appropriate infusion therapy can be substantial and may delay necessary treatment to the patient. Furthermore, there is a risk that the clinician will not determine the appropriate medication therapy for the particular patient condition. For this additional reason, a need has been identified for a medical device that will provide pre-programmed infusion therapies based on patient and condition data.
The present invention is provided to solve these and other problems.